SRC-PNG S.B. 645 76(R)   BILL ANALYSIS


Senate Research Center   S.B. 645
76R6521 MI-FBy: Lucio
Technology & Business Growth
4/13/1999
As Filed


DIGEST 

Currently, under Texas law, manufacturers and distributors of prescription
and nonprescription drugs are liable for punitive damages in product
liability actions, despite compliance with all federal standards for
product formulation, packaging, and labeling.  This bill would establish a
defense for punitive damages in which a drug manufacturer or distributor
has complied with the pre-marketing federal standards established by the
Food and Drug Administration. 

PURPOSE

As proposed, S.B. 645 establishes a defense for punitive damages in which a
drug manufacturer or distributor has complied with the pre-marketing
federal standards established by the Food and Drug Administration. 

RULEMAKING AUTHORITY

This bill does not grant any additional rulemaking authority to a state
officer, institution, or agency. 

SECTION BY SECTION ANALYSIS

SECTION 1. Amends Chapter 41, Civil Practice and Remedies Code, by adding
Section 41.014, as follows: 

Sec.  41.014.  COMPLIANCE WITH GOVERNMENT STANDARDS FOR DRUG SAFETY.
Defines "drug," "products liability action,""manufacturer," and "seller."
Prohibits exemplary damages from being awarded in a products liability
action against a manufacturer or seller of a drug that caused the
claimants' harm in certain situations. Provides that Subsection (b) does
not apply to a manufacturer of a drug if the claimant proves by clear and
convincing evidence that the manufacturer intentionally or wrongfully
withheld from or misrepresented to the federal Food and Drug Administration
(FDA) certain required information that is material and relevant to the
harm suffered by the claimant or made an illegal payment to an official or
employee of the federal FDA for the purpose of securing or maintaining
approval of the drug. 

SECTION 2. Effective date: September 1, 1999.
  Makes application of this Act prospective.

SECTION 3. Emergency clause.